Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
AVID Medical is recalling Halyard shoulder surgical kits due to loose metal flakes that could detach and enter surgical sites. Metal debris could cause local or foreign body reactions.
Siemens Healthcare is recalling certain IMMULITE 2000 PSA assay diagnostic kits because they do not perform as claimed for high-concentration samples used on IMMULITE 2000 analyzers.
AVID Medical is recalling 136 units of Halyard GYN TRAY surgical kits due to small loose metal flakes that could detach from sponge forceps and towel clamps. These metal fragments could enter a patient's surgical site undetected, causing local or foreign body reactions.
AVID Medical is recalling Halyard CPT Cardiac Cath Pack convenience kits due to small metal flakes that may detach from sponge forceps and towel clamps. Metal flakes could enter a surgical site undetected and cause local or foreign body reactions.
AVID Medical is recalling Halyard C Section Pack surgical kits due to loose metal flakes on sponge forceps and towel clamps. These flakes may enter a surgical site and cause local reactions or foreign body complications.
AVID Medical recalls Halyard PACEMAKER TRAY surgical kits nationwide due to potential loose metal flakes that could detach from sponge forceps and towel clamps and contaminate surgical sites.
AVID Medical is recalling Halyard RAD PACK medical convenience kits containing sponge forceps and towel clamps. Small metal flakes may detach and enter surgical sites, potentially causing foreign body or local tissue reactions.
AVID Medical is recalling Halyard CPT surgical convenience kits because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites. No illnesses have been reported.
The Metrix Company is recalling 2549 cases of SECURE 100 mL empty IV fluid bags because a limited number were found to leak during filling, which could result in contamination during fluid administration.
The Metrix Company is recalling Imed EVA IV fluid bags that may leak during filling. A limited number of units have been found defective across multiple U.S. states and Canada.
The Kroger Co is recalling Home Chef Asian Style Chicken Stir Fry due to potential contamination with Listeria monocytogenes. The recall affects 31,424 consumer units distributed across the United States.
Halyard abdominal procedure surgical kits may contain loose metal flakes in forceps and clamps that could enter the surgical site. Affected kits have lot number 1590888.
The FDA has recalled CORMIX 250 mL empty IV bags made by The Metrix Company due to leaking during the filling process. Approximately 3,456 cases were distributed across the US and Canada.
Medline has recalled 626,305 urine collection kits because specimen containers are labeled as sterile but are actually non-sterile, potentially leading to unnecessary treatment or prolonged hospitalization.
AVID Medical recalls Halyard ANGIO PACK surgical kits due to loose metal flakes that could detach and enter a patient's surgical site. The recall affects 284 units distributed nationwide.
Baxter is recalling 8 units of its Spectrum IQ Infusion System with Dose IQ Safety Software because the pump door may not fully close. The recall affects units distributed in Georgia and Idaho.
AVID Medical recalled Halyard POST PARTUM TUBAL LIGATION surgical kit components due to loose metal flakes that could detach from sponge forceps and towel clamps. Metal flakes entering a patient's surgical site could cause local or foreign body reactions.
Medline Industries is recalling over 626,000 urine collection kits due to specimen containers labeled as sterile but identified as non-sterile. The defect may result in unnecessary treatment or prolonged hospitalization.
The Metrix Company is recalling CORMIX 500 mL IV bag containers that may leak during the filling process. These plastic pouches are intended for intravenous fluid administration.
The Metrix Company is recalling Imed EVA IV bags due to leakage discovered during the filling process. A limited number of bags were found to leak, potentially affecting the safety of intravenous therapy.
AVID Medical is recalling Halyard KIT, TOTAL KNEE medical convenience kits due to loose metal flakes in sponge forceps and towel clamps that could contaminate surgical sites.
The Metrix Company is recalling SECURE 50 mL empty IV containers due to leakage found during filling. A limited number of affected bags have been distributed nationwide.
AVID Medical is recalling Halyard TOTAL KNEE surgical kits (Model EUOR002-05) because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites and cause reactions.
AVID Medical is recalling Halyard Shoulder Pack medical convenience kits because the sponge forceps and towel clamps contain loose metal flakes that could detach and enter a patient's surgical site during use, potentially causing foreign body reactions.
Stryker is recalling smoke evacuation pencils used in electrosurgery that may activate without manual input, creating a risk of electrical burns to patients or healthcare providers.